insulin degludec
Brand names: Tresiba
Xultophy 100/3.6 is a combination of two medicines, insulin degludec and liraglutide. It helps control blood sugar in adults with type 2 diabetes, along with diet and exercise.
Drug Pricing (NADAC)
Brand Price
$32.52/unit
Generic Price
$11.39/unit
Generic Savings
65%
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Xultophy 100/3.
Common side effects
Common cold, Headache, Feeling sick to your stomach
Key warnings
Xultophy 100/3.
How It Works
This medicine contains insulin degludec, which is a long-acting form of insulin that helps lower blood sugar levels. It also contains liraglutide, which is a GLP-1 receptor agonist. Liraglutide works by helping your body release insulin when your blood sugar is high and by slowing down the emptying of food from your stomach.
How to Take It
Inject Xultophy 100/3.6 once a day at the same time each day. You can take it with or without food. The pen delivers doses from 10 to 50 units per injection. The maximum daily dose is 50 units. Inject it under the skin of your thigh, upper arm, or abdomen, and rotate injection sites.
Pregnancy & Breastfeeding
Xultophy 100/3.6 should only be used during pregnancy if the benefit outweighs the risk to the baby. Animal studies with liraglutide, one of the medicines in this drug, have shown risks to the fetus. Talk to your doctor if you are pregnant or plan to become pregnant.
Missed Dose
If you miss a dose of Xultophy 100/3.6, take it as soon as you remember. However, do not take a double dose to make up for the missed dose.
Storage
Before first use, store Xultophy 100/3.6 in the refrigerator between 36°F to 46°F (2°C to 8°C). After first use, you can store the pen at room temperature (59°F to 86°F) or in the refrigerator for up to 21 days.
Side Effects (from patient reports)
Based on 12,391 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 22,011 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2011–2025.
Total Reports
22,011
Death-Related Reports
1,194
Hospitalization Reports
6,329
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BLOOD GLUCOSE INCREASED | 3,617 |
| 2 | NAUSEA | 1,381 |
| 3 | BLOOD GLUCOSE DECREASED | 1,252 |
| 4 | DRUG INEFFECTIVE | 963 |
| 5 | OFF LABEL USE | 901 |
| 6 | VOMITING | 894 |
| 7 | HYPOGLYCAEMIA | 886 |
| 8 | DIARRHOEA | 876 |
| 9 | FATIGUE | 861 |
| 10 | DYSPNOEA | 760 |
| 11 | FALL | 673 |
| 12 | DIZZINESS | 652 |
| 13 | HEADACHE | 634 |
| 14 | CONSTIPATION | 623 |
| 15 | MALAISE | 549 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Xultophy 100/3.6 may increase your risk of thyroid C-cell tumors. Liraglutide, one of the medicines in Xultophy 100/3.6, caused these tumors in animals. It is not known if Xultophy 100/3.6 causes thyroid tumors in humans. You should not take this medicine if you have a personal or family history of medullary thyroid carcinoma (MTC) or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your doctor if you notice a lump in your neck, have trouble swallowing or breathing, or if your voice becomes hoarse.
Known Drug Interactions
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: Fluoxetine can increase the effect of insulin, which makes your blood sugar more likely to drop to unsafe levels.
What to do: Check your blood sugar more often and talk to your doctor about adjusting your insulin dose.
7.2 Effects of Delayed Gastric Emptying on Oral Medications Liraglutide-containing products, including XULTOPHY 100/3.6, cause a delay of gastric emptying, and thereby have the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree [see Clinical Pharmacology ( 12.3 )] . Nonetheless, caution should be exercised when oral medications are concomitantly administered with liraglutide containing products.
Mechanism: Liraglutide slows down the movement of food and medicine through your stomach, which can change how your body absorbs pills.
What to do: Be careful when taking oral medicines with this drug and watch for changes in how well your other medicines work.
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: Both drugs work to lower blood sugar, so taking them at the same time can cause your blood sugar to drop too low.
What to do: You should monitor your blood sugar levels closely and your doctor may need to lower your insulin dose.
Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics Intervention: Dosage reductions and increased frequency of glucose monitoring may be required when XULTOPHY 100/3.6 is coadministered with these drugs.
Mechanism: This medication can make your body more sensitive to insulin, which increases the risk of having low blood sugar.
What to do: Your doctor may need to lower your insulin dose, and you should check your blood sugar more frequently.
Drugs That May Decrease the Blood Glucose Lowering Effect of XULTOPHY 100/3.6 Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.
Mechanism: Albuterol can decrease the blood-sugar-lowering effect of insulin. This can lead to higher blood sugar levels while you are using the medication.
What to do: Monitor your blood sugar levels closely if you are using albuterol. Your healthcare provider may need to adjust your insulin dose.
Common Questions
What should I do if I experience symptoms of a thyroid tumor?
Can I use Xultophy 100/3.6 if I have a history of pancreatitis?
What should I do if I experience symptoms of low blood sugar?
Can I share my Xultophy 100/3.6 pen with others?
What if I accidentally inject too much Xultophy 100/3.6?
Can other medications affect Xultophy 100/3.6?
How do I dispose of used Xultophy 100/3.6 pens and needles?
Can Xultophy 100/3.6 cause kidney problems?
What are the symptoms of a serious allergic reaction?
Does Xultophy 100/3.6 have to be refrigerated?
What are the common side effects of insulin degludec?
Does insulin degludec interact with other medications?
What drug class is insulin degludec?
Is there a generic version of insulin degludec?
Is insulin degludec safe during pregnancy?
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What the FDA Data Shows for insulin degludec
The FDA label for insulin degludec (sold under brand names such as Tresiba) classifies it as a prescription-only medication in the Ultra-Long-Acting Insulin class. Xultophy 100/3. Official labeling lists 6 commonly reported side effects, including Common cold, Headache, Feeling sick to your stomach.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 12,391 voluntary reports. The database also lists 12 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $11.39 versus $32.52 for the brand — a 65% generic savings.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 14, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages